Status:
COMPLETED
Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)
Lead Sponsor:
Travere Therapeutics, Inc.
Conditions:
Focal Segmental Glomerulosclerosis
Immunoglobulin A Nephropathy
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this observational study is to assess humanistic burden among adults and children/adolescents with FSGS and IgAN as well as the burden and impact for patient care-partners in six countries ...
Eligibility Criteria
Inclusion
- Adult patients and their adult care-partners: At least 18 years old; Either have a physician-provided diagnosis of FSGS or IgAN (with renal biopsy confirmation of the diagnosis) or being a care-partner for someone with a physician-provided diagnosis of FSGS or IgAN (with renal biopsy confirmation of the diagnosis);
- Able to provide informed consent;
- Located in the United States (US), United Kingdom (UK), Germany, France, Spain or Italy.
- \*Care-partners (paired with adult patients) (defined as the individual \[e.g., spouse, parent, sibling, relative, or friend\] providing direct disease-related support to the adult patient.
- \*\*All patient groups including chronic kidney disease (CKD) stage 1-5, with or without dialysis, and with or without kidney transplant will be included.
- Care-partners/parents of children/adolescents: At least 18 years old;
- Being a care-partner of children/adolescents with physician-provided diagnosis of FSGS or IgAN (with renal biopsy or genetic confirmation of the diagnosis);
- Able to provide informed consent; Located in the US, UK, Germany, France, Spain or Italy.
- Care-partners will be defined as family members who provide disease-related support and unpaid care to child/adolescent patients
Exclusion
- Patient has FSGS or IgAN secondary to another condition;
- Patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer;
- Patient has a co-existing glomerular disease (e.g., membranous nephropathy, lupus nephritis);
- Patient is currently participating in a kidney disease clinical trial, and potentially receiving active treatment as part of the trial.
Key Trial Info
Start Date :
February 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
487 Patients enrolled
Trial Details
Trial ID
NCT05200871
Start Date
February 5 2022
End Date
October 31 2023
Last Update
February 21 2024
Active Locations (6)
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1
Travere Investigational Site
San Francisco, California, United States, 94115
2
Travere Investigational Site
Belmar, New Jersey, United States, 07719
3
Travere Investigational Site
Chapel Hill, North Carolina, United States, 27599
4
Travere Investigational Site
King of Prussia, Pennsylvania, United States, 19406